The New Scientist piece below (item 1) points to the inadequacy of planned
safeguards for the growing of powerful pharmaceuticals in food plants.
As the Purdue University fact sheet (item 2) makes clear, this is not a
food safety issue of the future. Open air production of pharmaceutically
related products in corn is already underway on hundreds of acres in the
US's western Corn Belt, including Iowa, one of the states worst affected
by the Starlink debacle. In that case a corn not approved for human consumption,
which was being grown on relatively few acres, caused widescale contamination
of the food chain. As ABC NEWS reported at the time, "In Iowa, StarLink
corn represented 1 percent of the total crop, only 1 percent. It has tainted
50 percent of the harvest." (ABC NEWS, November 28, 2000)

Loopholes in US regulations raise fears that food crops will be contaminated
with pharmaceuticals

THE rules the US government is proposing for field tests of crops that
have been genetically modified to produce pharmaceutical products are not
strict enough to prevent the contamination of food crops, experts have
told New Scientist.

They say the proposed rules are based on flawed science, that there
are loopholes allowing them to be bypassed, and that companies do not even
have to disclose what genes have been added. And they warn of severe environmental
consequences if a drug-laced plant were to breed with other crops or wild
relatives.

Biotech companies plan to produce a vast range of products, from drugs
to vaccines, in plants. "These plants have the potential for more benefit
than any other agribiotech product," says Jane Rissler of the Union of
Concerned Scientists in Washington DC. "But to realise those benefits we
have to be very careful about the risks." The US Department of Agriculture's
(USDA) plans don't come close, she says. What scares Rissler and others
is that there could be a rerun of the Starlink debacle, in which GM corn
strictly not intended for human consumption ended up on grocery shelves.
If any contamination involved a crop producing a potent drug, the consequences
could be far more serious, she says.

The proposed rules require the "pharmed" plants to be separated from
other crops in time as well as space. For example, pharmed maize must be
grown at least 400 metres away from other maize. It must also be planted
two weeks before or after nearby crops, so that it isn't fertile at the
same time. Similar regulations have been outlined for other plants that
have been engineered to make drugs, including barley, corn, rice and sugar
cane. But when it comes to keeping harvested products separate, the rules
are vague, talking only of "adequate identification, packaging and segregation".

Companies that violate these procedures can be fined dollars 250,000,
and individuals could face jail sentences of up to five years. James White,
the USDA's branch chief for biotech evaluations, is confident the rules
will do their job&colon;"The chance of gene flow is essentially zero."

"These rules are more stringent than prior recommendations, and I applaud
that," says Norman Ellstrand of the University of California, Riverside,
who sat on a National Academy of Sciences committee that reviewed the regulations
for GM crops. "But there are big holes in the system."

The NAS report points out that some of the USDA's rules have no clear
scientific rationale. For instance, the isolation distance for corn is
simply double the 200 metres it recommends for the production of GM seeds.
The assumption is that this spacing will reduce contamination to 0.1 per
cent, but there is no evidence that the contamination risk drops off with
this increase in distance. Only last week, Australian researchers reported
that pollen from oilseed rape had contaminated fields up to 3 kilometres
away, and that there was no obvious drop-off with distance (Science, vol
296, p 2386).

Another serious concern is that the USDA focuses on the intended use
of a crop product and ignores its other possible impacts. For instance,
the Texas-based company Prodigene applied to grow maize that produces a
chicken-egg protein called avidin, which is known to kill or harm 26 species
of insects. But because avidin is not classed as a drug, the crop doesn't
come under the pharming regulations. Nor did the USDA look at the maize's
environmental impact because the crop wasn't being grown in order to kill
insects. "If they had used the same protein as an insecticide, they would
have called in the Environmental Protection Agency to regulate it," says
Ellstrand.

While avidin's properties are well known, that is not the case with
every drug that might end up being grown in crops. Ellstrand and his colleagues
were disturbed to discover that the publicly available descriptions of
genes spliced into some plants are incredibly vague.

White says the USDA will start posting fact sheets on genes in transgenic
plants later this month. When a company wants to keep the identity of a
gene secret, it will give it a code name and a general description, such
as "Gene S is a hormone in humans. It is harmless to invertebrates," and
so on.

He also says the only drugs so far being grown in crops are proteins
that would simply be digested if accidentally eaten by humans or animals.
"The risks are minimal," White says. "No one is making Viagra in a field."
But there's nothing to stop companies producing a Viagra crop if they want
to. "It's a disaster waiting to happen," says Doreen Stabinsky, a science
adviser for Greenpeace. "Grow this stuff in a greenhouse or a cave, not
in an open field where animals can grab the seeds."

Ellstrand agrees that stricter containment is needed. Pharmed plants
could be genetically engineered to prevent gene flow using methods such
as the infamous Terminator technique, which makes seeds sterile, or a newly
proposed one dubbed the Exorcist (see "Begone! evil genes"). And to be
absolutely certain the food supply is safe, he argues that only plants
that aren't grown for food should be used to make drugs.

White points out that when the long-awaited regulations are finally
published, the public will have 120 days to respond. "I wouldn't be surprised
if we got thousands of letters telling us: not in food."

An April 10 Reuters press release (www.reuters.com) indicates that a
biotechnology company, ProdiGene ® , College Station, TX (www.prodigene.com),
through a grant from the National Institutes of Health (NIH), has produced
a transgenic corn variety that contains a protein found on the surface
of HIV, the virus that causes AIDS. The company's intent is to utilize
such corn in the future as an oral delivery system for an AIDS vaccine,
through corn-based products such as breakfast cereals. This transgenic
corn variety apparently has been grown on enough acres already to produce
sufficient quantities of grain to begin animal studies during the summer
of 2002, to determine whether ingestion of this corn elicits an immune
response.

Five other transgenic corn hybrids from Prodigene ® have been released
commercially via Stauffer Seeds ® , Omaha, NE (www.StaufferSeeds .com),
and have been grown by a select group of farmers on a few hundred acres
primarily in the western Corn Belt, much of it in western Iowa and on irrigated
acres in Nebraska. These hybrids contain:
Aprotinin - a protease inhibitor that is used in medical applications
to control blood loss during surgery and in non-medical applications as
a cellculture reagent.
Avidin - a protein that binds with biotin to make useful products for
the medical and biochemical diagnostics industry and has application in
protein purification.
Laccase - an industrial enzyme used for adhesives in the manufacturing
of medium density fiberboard (MDF) as well as in the detergent industry
as an environmentally friendly bio-bleach
Brazzein - a low calorie, intense natural sweetener 2000 times sweeter
than sucrose.
Trypsin - a protease enzyme that has many uses including as an intermediate
in pharmaceutical manufacturing and in the leather tanning and detergent
industries.

Additional protein-based drugs and industrial compounds produced from
genetically modified (GM) field crops are currently under development by
several companies and are expected to be ready for commercial release approval
within a few years.

Prodigene's oral vaccine products including hepatitis-B vaccine, Lt-B
vaccine to treat E. coli in humans, TGEV vaccine to treat the transmissible
gastroenteritis virus that kills thousands of piglets every year, and additional
confidential animal vaccines and human health products under development
with such partners as Eli Lilly and Avant Immunotherapeutics.

Various seed companies that are partnering with biotechnology firms
are already recruiting farmers, and in some instances crop acres have been
acquired by foreign biotechnolgy companies such as Meristem Therapeutics
Inc., Clermont-Ferrand, France (www.meristem-therapeutics.com), for experimental
testing on private farmland throughout the midwestern Corn Belt.

[EXCERPTS FROM THE REST OF THE FACT SHEET]

Contamination Concern

...the fact that transgenic grains and oilseeds for use as pharmaceutical
drug carriers and industrial chemicals may be making their way into a field
near your farm, grain elevator, feed mill or processing plant should be
a concern, especially in light of the grain industry‚s most recent contamination
experiences with Aventis‚ StarLink· corn, which contains a protein approved
for feed but not food consumption, and Monstanto‚s GT200- containing canola
seed, which contains a protein not approved for any end use. Both of these
crops were grown on relatively few acres, yet containment protocols to
channel or identity-preserve (IP) them at the seed plant, on the farm,
and/or at the elevator failed to prevent trace amounts above detectable
limits in commercial feed and food bulk grain samples taken from domestic
and export market channels. Experience and science-based research tell
us that no identity preservation system will ever be able to contain 100%
of every seed kernel, plant pollen and grain kernel generated from crops
grown in agricultural fields. The very definition of a quality-management-
system approach to segregated and traceable production, harvesting, handling
and transport of IP grains and oilseeds is based on defining, meeting and
monitoring statistically-based threshold limits that are reasonable and
practically achievable with respect to containment, purity and contamination.

Concern over Lack of Federally Regulated Tolerance Levels

Successful identity preservation has been the backbone of the seed industry
for years. Most of us would consider seed producers among the most educated,
dedicated and best equipped with respect to maintaining the identity of
a crop and preventing that crop from contaminating or being contaminated
by another crop during planting, growing, harvesting, post-harvest handling
and transporting.

Yet the seed industry cannot achieve 100% pure IP seed during production,
handling, cleaning and bagging. Instead, a contamination level of 1% is
the strictest limit the industry states can be achieved reasonably and
practically, with respect to seed purity (www.amseed.com/intl_network.asp
). The principle challenge for IP systems is that whenever new genetic
material is introduced into the agricultural crop mix, trace contamination
of non-target crops is unavoidable. This fact is common knowledge in the
seed industry. Trace amounts, above detectable limits, of a newly commercialized
genetic event are often detected whenever stored seed samples of three-
to five-year old pre-commercialization varieties are tested, following
the release of a new test kit. Thus, if containment of undesired or unapproved
genetic events is not 100% effective, for the purpose of seed purity, it
will also not be effective for the purpose of crop purity, especially as
more GM traits for pharmaceutical and industrial compounds in grains and
oilseeds are commercialized.

Therefore, federally-regulated tolerance levels based on detectable
thresholds similar to the Environmental Protection Agency‚s (EPA) pesticide
residue limits and the Food and Drug Administrations‚ (FDA) mycotoxin limits
are urgently needed to define the allowable residue limits of pharmaceutical
and industrial compounds in grains and oilseeds for food and feed use.
Additionally, availability of reliable and inexpensive testing technology
such as strip test kits for grain elevator use must become mandatory with
the commercial release of every new genetic event in order to give the
U.S. grain production, handling, exporting and processing industry the
competitive advantage to meet customer demands with respect to the presence
of approved but undesired GM-crop traits below established tolerance levels.

...It cannot be assumed that trace contamination of non-target crops
is avoidable and the possibility cannot be ignored that an active ingredient
could be expressed so highly concentrated that a single kernel might exceed
food safe exposure limits. Therefore, the major world food and feed staple
crops should not be used for transgenic modifications for the purpose of
expressing pharmaceutical ingredients and industrial chemicals, unless
they can meet food safety requirements.

If the federal government does not intervene with threshold limits and
stricter regulation and oversight soon, it will be just a matter of time
before trace amounts of unapproved and non-food/feed-safe pharmaceutical
and industrial proteins will be detected in our domestic and export food
and feed market channels.

This potential scenario will likely cause a far greater public outcry
than did the StarLink discovery in taco shells. The future use of the world's
major food and feed staple crops for the development of edible vaccines
and other protein-based drugs and industrial chemicals on a few thousand
acres far outweigh the risk of jeopardizing the United States‚ domestic
and export markets due to contamination of grains and oilseeds produced
on millions of acres for the purpose of satisfying the world's food and
feed demand.

Grain Quality Fact Sheets can be accessed on-line through the World
Wide Web at: http://www.agcom.purdue.edu/AgCom/Pubs/grain.htm (select)
Grain Quality or http://www.GrainQuality.org